FDA Adverse Event Malfunction Summary report: N

HOMECHOICE PRO

MDR report key: 3900047 · Received June 27, 2014

Report

Report Number: 1416980-2014-20635
Event Type: Malfunction
Date Received: June 27, 2014
Date of Event: April 26, 2014
Report Date: June 4, 2014
Manufacturer: ER HEALTHCARE - LARGO
Product Code: FKX
PMA / PMN Number: K102936
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: EZ
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). EVALUATION: THE DEVICE WAS RETURNED TO BAXTER AND THE EVALUATION IS COMPLETE. THIS COMPLAINT IS AN ANCILLARY SERVICE EVENT. THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS VERIFIED THROUGH AN EVENT HISTORY LOG REVIEW. THE CAUSE WAS USE ERROR, TIDAL TOTAL UF REMOVAL SET TOO LOW. HOMECHOICE APD SYSTEMS TRAINER¿S GUIDE GIVES INSTRUCTIONS ON HOW TO SET THE TIDAL THERAPY SETTINGS. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

DURING EVALUATION OF A RETURNED HOMECHOICE DEVICE, AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED. THIS OCCURRED DURING THE THERAPY INITIATED ON (B)(6) 2014 AT 20:24:26. DURING NIGHT DRAIN CYCLE TEN, THE PATIENT'S ULTRAFILTRATION READING WAS 1691ML, INDICATING THE HOME PATIENT (HP) DRAINED 1291ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 2000ML. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
378231	HOMECHOICE PRO	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	ER HEALTHCARE - LARGO

Patients

Seq	Age	Sex	Outcome	Treatment
1